Pharmacoepidemiological Safety Study of Neuroleptics and Antidepressants in the Area of Geriatric Psychiatrics (PhaSiNAg)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N05A) ANTIPSYCHOTICS

  ANTIPSYCHOTICS

  (N06A) ANTIDEPRESSANTS

  ANTIDEPRESSANTS
• Medical condition to be studied:
  Ventricular arrhythmia

  Cardiac failure

  Pneumonia

  Ischaemic stroke

  Hip fracture

  Death

  Embolism venous

Population studied

• Short description of the study population:
  neuroleptics (NLs) and antidepressants (ADs) users aged 65 years and older.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  523000

Study design details

• Main study objective:
  To estimate the risk of acute myocardial infarction, heart failure, ventricular arrhythmia, ischemic stroke, hip fracture and all-cause mortality for incident users of NLs and ADs aged 65 years and older and to compare these risks between individual drugs and drug classes. For incident NL users, the outcomes pneumonia and venous thromboembolism will also be investigated.
• Outcomes:
  Acute myocardial infarction, heart failure, ventricular arrhythmia, ischemic stroke, hip fracture, pneumonia, venous thromboembolism and all-cause mortality.
• Data analysis plan:
  For the primary and secondary analysis, Cox models will be used to estimate the adjusted hazard ratio for each outcome in the NL (reference group: atypical neuroleptic) and antidepressant (reference group: tri- and tetracyclic antidepressants) drug classes and for frequently used individual drugs (reference group neuroleptic: risperidone, reference group antidepressants: citalopram). The time-scale for the time-to-event analysis is the time in the cohort until occurrence of an outcome or censoring at the end of cohort time. Pre-defined a priori covariates such as age, sex, and prior history of selected co-morbidity and co-medication will always be included in the model. A backward selection (p=0.05) will be performed to include additional covariates in the model.